EP4111939B1 - Biopsy cap and biopsy cap housing - Google Patents
Biopsy cap and biopsy cap housing Download PDFInfo
- Publication number
- EP4111939B1 EP4111939B1 EP22186025.7A EP22186025A EP4111939B1 EP 4111939 B1 EP4111939 B1 EP 4111939B1 EP 22186025 A EP22186025 A EP 22186025A EP 4111939 B1 EP4111939 B1 EP 4111939B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- biopsy cap
- center
- biopsy
- split
- cap assembly
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
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- 230000013011 mating Effects 0.000 claims description 25
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- 239000005060 rubber Substances 0.000 description 2
- 238000012800 visualization Methods 0.000 description 2
- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00131—Accessories for endoscopes
- A61B1/00137—End pieces at either end of the endoscope, e.g. caps, seals or forceps plugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00064—Constructional details of the endoscope body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00064—Constructional details of the endoscope body
- A61B1/0011—Manufacturing of endoscope parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00131—Accessories for endoscopes
- A61B1/0014—Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00147—Holding or positioning arrangements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
- A61B1/015—Control of fluid supply or evacuation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
- A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/04—Endoscopic instruments
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
- B29D99/00—Subject matter not provided for in other groups of this subclass
- B29D99/0053—Producing sealings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
- A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0626—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with other surgical instruments, e.g. endoscope, trocar
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
- A61M2039/064—Slit-valve
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
- A61M2039/0653—Perforated disc
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0686—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising more than one seal
Definitions
- the present disclosure relates generally to the field of medical instruments. More particularly, the present disclosure pertains to medical instruments for use with an endoscope, such as a biopsy cap and a biopsy cap housing with improved stability and stress distribution, for example, to securely attach to an endoscope biopsy port.
- an endoscope such as a biopsy cap and a biopsy cap housing with improved stability and stress distribution, for example, to securely attach to an endoscope biopsy port.
- Conventional endoscope biopsy cap housings and biopsy caps can include a variety of deficiencies which may contribute - both individually and cumulatively - to component breakage, unnecessarily complicated or additional procedural steps and/or prolonged procedure times.
- conventional biopsy cap housings tend to permit axial and rotational movement of the housing and/or cap during device exchange.
- exchange of larger diameter medical instruments e.g., catheters, stent introducers, etc .
- Adhesives applied to the center-split halves may minimize such separation but result in increased assembly time and cost.
- Locking or unlocking a guidewire to the hook(s) located on one side of a conventional biopsy cap housing tends to exert a radially outward force on one of the center-split halves, which may cause the center-split halves to move in opposite directions and partially or completely separate/disengage from each other.
- Excessive flexing due to lateral forces applied to one or both center-split halves, e.g ., during disengagement of the biopsy cap housing from the biopsy port may concentrate stress on the locks which secure the biopsy cap housing to the endoscope port, resulting in a fracture of one or more of the locks.
- Prior art document US 2006/195117 discloses a wire guide holder having a seal and a body is provided.
- the seal is adapted to receive a wire guide, and the body is attached to the seal and is adapted to be attached to an elongate medical tube.
- the elongate medical tube may include an endoscope.
- the endoscope may have an access port and an insert, and the body may be affixed to the access port.
- the body may also be affixed to an insert, insert groove, or insert rim.
- the body may be snap-fit together.
- biopsy cap and biopsy cap housing embodiments of the present disclosure A variety of advantageous medical outcomes may therefore be realized by the biopsy cap and biopsy cap housing embodiments of the present disclosure.
- the present disclosure relates to a biopsy cap housing comprising a first center-split half and a second center-split half.
- the first center-split half may include a first portion defining a first half of an upper chamber and a second portion defining a first half of a lower chamber.
- a first pivot member may be integrally formed with the first portion of the first center-split half.
- a first slit may extend through a sidewall of the first and second portions of the first center-split half and in substantial alignment with the first pivot member.
- the second center-split half may include a first portion defining a second half of the upper chamber and a second portion defining a second half the lower chamber.
- a second pivot member may be integrally formed with the first portion of the second center-split half.
- a second slit may extend through a sidewall of the first and second portions of the second center-split half and in substantial alignment with the second pivot member.
- Mating surfaces of the first and second center-split halves may be configured to interlock to define the upper and lower chambers.
- an elevated surface of the first pivot member may extend into the upper chamber and an elevated surface of the second pivot member may extend into the upper chamber substantially opposite the first pivot member.
- the upper chamber may be configured to receive a biopsy cap.
- the lower chamber may be configured to receive an endoscope biopsy port.
- the first and second pivot members may include a thickness greater than a wall thickness of the first and second center-split halves. A force applied to the first portions of the first and second center-split halves may move the second portions of the first and second center-split halves away from each other. A force applied to the second portions of the first and second center-split halves may move the first portions of the first and second center-split halves away from each other.
- the elevated surfaces of the first and second pivot members may be configured to engage a corresponding recessed portion formed within an outer wall of a biopsy cap disposed within the upper chamber.
- a first locking hook may be attached to a proximal end of the first center-split half and a second locking hook may attached to a proximal end of the second center-split half.
- the first and second locking hooks may be substantially adjacent to each other when the first and second center-split halves are interlocked.
- An inner surface of the first portions of the first and second center-split halves may include a surface feature configured to engage a corresponding surface feature formed on or within an outer wall of a biopsy cap disposed within the upper chamber.
- the surface feature of the housing may include a lip extending into a proximal end of the upper chamber.
- the surface feature of the biopsy cap may include a wedge extending inward from a top surface of the biopsy cap.
- the lip may be configured to engage the top surface of the wedge of the biopsy cap.
- the surface feature of the housing may include a wedge formed within the inner surfaces of the first and second portions of the first and second center-split halves.
- the surface feature of the biopsy cap may include a wedge extending outward from an outer wall of the biopsy cap top.
- the wedge of the housing may be configured to engage the wedge of the biopsy cap.
- the mating surface of the first center-split half may include one or more projections and the mating surface of the second center-split half may include one or more receiving elements.
- the projections may be configured to be received within corresponding receiving elements.
- the one or more projections may include one or more pins and the one or more receiving elements may include one or more pin holes.
- the one or more pins and corresponding one or more pin holes may be located at a proximal end of the first portions of the first and second center-split halves.
- the one or more pins and corresponding one or more pin holes may be located at a proximal end of the second portions of the first and second center-split halves.
- the one or more projections may include one or more pegs and the one or more receiving elements may include one or more sockets.
- the one or more pegs and corresponding one or more sockets may be located at a proximal end of the second portions of the first and second center-split halves.
- the one or more projections may include one or more snap-locks and the one or more receiving elements may include one or more snap-lock receivers.
- the one or more snap-locks and corresponding one or more snap-lock receivers may be located at a proximal end of the first portions of the first and second center-split halves.
- the one or more snap-locks and corresponding one or more snap-lock receivers may be located at a proximal end of the second portions of the first and second center-split halves.
- the one or more snap-locks may include an angled surface configured to positively engage a corresponding angled surface of the one or more snap-lock receivers.
- An inner surface of the second portions of the first and second center-split halves may include one or more locking members extending into the lower chamber and configured to releasably engage an outer surface of an endoscope biopsy port disposed within the lower chamber.
- An inner surface of the second portions of the first and second center-split halves may include one or more platforms extending into the lower chamber on opposite sides of the first and second slits and between the one or more locking members.
- An end of the one or more locking members and a surface of the one or more platforms may be separated by a distance within the lower chamber when a force is not applied to the first portions of the first and second center-split halves.
- An end of the one or more locking members and a surface of the one or more platforms may be in contact when a force is applied to the first portions of the first and second center-split halves.
- the force applied to the first portions of the first and second center-split halves may be an inward compressive force configured to move the second portions of the first and second center-split halves away from each other.
- the contact between the one or more locking members and the surface of the one or more platforms may prevent at least one of the locking members from breaking due to over-extension.
- the present disclosure relates to a biopsy cap comprising one or more surface features formed on or within the biopsy cap.
- the one or more surface features may be configured to frictionally and/or compressingly engage a corresponding surface feature formed on or within an inner surface of a first portion of first and second center-split halves of a biopsy cap housing.
- the biopsy cap may include a first surface feature attached to or integrally formed with a proximal end of the biopsy cap and second and third surface features attached to or integrally formed with an outer wall of the biopsy cap.
- the one or more surface features may include first and second recessed portions integrally formed within an outer wall of the biopsy cap and separated from the second and third surface features by approximately 90-degrees relative to an outer circumference of the biopsy cap.
- the biopsy cap may be formed from or otherwise include a variety of compressible materials (e.g ., silicone, rubbers, etc.) formed as a single unitary structure using.
- the surface feature may include a substantially contiguous lip.
- the surface feature may include substantially contiguous wedges.
- the surface feature may include recessed portions.
- the present invention as defined in independent claim 1 relates to a biopsy cap assembly comprising a first center-split housing half and a second center-split housing half.
- the first center-split half may include a first portion defining a first half of an upper chamber and a second portion defining a first half of a lower chamber.
- a first pivot member may be integrally formed with the first portion of the first center-split half.
- the second center-split half may include a first portion defining a second half of the upper chamber and a second portion defining a second half the lower chamber.
- a second pivot member may be integrally formed with the first portion of the second center-split half.
- Mating surfaces of the first and second center-split housing halves may be configured to interlock to define the upper and lower chambers.
- an outer wall of the biopsy cap may include recessed portions formed therein.
- An elevated surface of the first pivot member may extend into the upper chamber and an elevated surface of the second pivot member may extend into the upper chamber substantially opposite the first pivot member. The elevated surfaces may frictionally engage the recessed portions of the biopsy cap.
- the first and second pivot members may include a thickness greater than a wall thickness of the first and second center-split housing halves.
- the housing may include a lip extending into a proximal end of the upper chamber and the biopsy cap may include a wedge extending outward from a top surface of the cap. The lip may be configured to engage the top surface of the wedge.
- the housing may include a wedge formed within the inner surfaces of the first and second portions of the first and second center-split housing halves.
- the biopsy cap may include a wedge extending outward from an outer wall of the biopsy cap top.
- the wedge of the housing may be configured to engage the wedge of the biopsy cap.
- biopsy caps and biopsy cap housings configured to allow the delivery and/or exchange of a variety of medical instruments through the biopsy cap and port of an endoscope, laparoscope, or other visualization systems such as the Spy Glass TM Direct Visualization System (Boston Scientific Corp., Marlborough, MA), it should be appreciated that such designs may be adapted to fit and/or be used with a variety of medical instruments and medical applications which include sealable access.
- distal refers to the end farthest away from the medical professional when introducing a device into a patient
- proximal refers to the end closest to the medical professional when introducing a device into a patient
- features and advantages of providing sealable access to a working channel may be realized in combination with a biopsy cap and biopsy cap housing.
- Such sealable access to a working channel which may be reinforced, may be implemented with features throughout the disclosures of United States Patent Application Serial No. 16/100,960, filed August 10, 2018 and titled “Biopsy Cap For Use With Endoscope,” United States Patent Application having an Attorney Docket No. 8150.0613, filed on even date herewith and titled “Attachments For Endoscopes," United States Patent Application having an Attorney Docket No.
- a biopsy cap housing of the present disclosure may include first and second center-split halves 110a, 110b (e.g., first and second housing portions or pieces) configured to mate or interlock with each other to define a first portion 112a, 112b, ( e.g., an upper chamber, first chamber, top chamber, etc.) configured to securely receive a biopsy cap 300 ( e.g. in FIG. 2 ) and a second portion 122a, 122b, ( e.g., a lower chamber, second chamber, bottom chamber, etc.) configured to securely and reversibly engage the neck 610 of an endoscope biopsy port 400 ( FIG. 4A ).
- first and second center-split halves 110a, 110b e.g., first and second housing portions or pieces
- first and second housing portions or pieces configured to mate or interlock with each other to define a first portion 112a, 112b, ( e.g., an upper chamber, first chamber, top chamber, etc.) configured to securely receive
- a first center-split half 110a (e.g., first side, lock side, etc.) of the biopsy cap housing 100 may include a first ( e.g., top, upper) portion 112a defining a first half ( e.g., a substantially hemi-cylindrical half) of the upper chamber, and a second ( e.g., bottom, lower) portion 122a defining a first half ( e.g., a substantially hemi-cylindrical half) of the lower chamber.
- a first locking hook 123a (e.g ., guidewire locking hook) and a guide are 130 may be attached to or integrally formed with a proximal end of the first portion 112a.
- a first pivot member 114a (e.g., first pivot button, first pivot feature, etc.) may be integrally formed with an approximate midpoint of the first portion 112a, and a first slit 126a ( e.g., opening, slot, etc.) may extend through a sidewall of the first and second portions 112a, 122a and in substantial alignment with ( e.g., on the same side as, directly below, etc.) the first pivot member 114a.
- the first pivot member 114a may include a substantially radially raised or elevated surface (e.g ., enlarged portion, projection, etc.) extending into the first half of the upper chamber, e.g., to engage a corresponding recessed portion 312a formed within an outer wall of a biopsy cap 300 ( FIG. 2 ).
- a substantially radially raised or elevated surface e.g ., enlarged portion, projection, etc.
- an inner surface of the first portion 112a of the first center-split half 110a may include a surface feature(s) configured to compressingly and/or frictionally engage a corresponding surface feature of a biopsy cap.
- the surface feature(s) may include a lip 117a ( e.g., step feature, etc.) integrally formed with an inner wall of the first center-split half 110a and extending into the first half of the upper chamber at or near a proximal end of the first portion 112a.
- the surface feature(s) may include a pair of wedges 116a (e.g ., indentations, recessed portions, etc.) formed within the inner wall of the first portion 112a distal to the lip 117a and on opposite sides ( e.g., separated by approximately 180 degrees) of the first half of the first portion 112a.
- a pair of wedges 116a e.g ., indentations, recessed portions, etc.
- one or more locking members 124a may be attached to or integrally formed with an inner wall of the first center-split half 110a at or near a proximal end of the second portion 122a and on opposite sides ( e.g ., separated by approximately 180 degrees) of the first half of the second potion 122a.
- the locking member(s) 124a may be configured to releasably engage a biopsy port 400 ( e.g., at neck 410) disposed within the second portion 122a ( FIG. 4A ).
- an end of the locking member(s) 124a may include a pair of substantially perpendicular surfaces 125a, 127a configured to engage ( e.g., contact, fit within, etc.) a substantially 90-degree surface (e.g., a bottom or lower surface of a lip) of the neck 410 of the biopsy port 400.
- one or more platforms e.g., stops, etc.
- one or more projections may be attached to or integrally formed with a mating surface 111a of the first and second portions 112a, 122a of the first center-split half 110a.
- the projection(s) may include one or more pins 118a ( e.g., posts, rods, etc.) with a substantially spherical or cylindrical outer dimension.
- the projections(s) may include one or more pegs 119a ( e.g., blocks, etc.) with a substantially square or rectangular outer dimension.
- the projections(s) may include one or more snap-locks 120a ( e.g., arms, etc.) with a substantially curved or hooked end.
- two pins 118a may extend from the mating surface 111a at or near a proximal end of the first portion 112a and two pins 118a may extend from the mating surface 111a adjacent to the locking member(s) 124a.
- Two snap-locks 120a may extend from the mating surface 111a at or near the proximal end of the first portion 112a and proximal to the pins 118a and two snap-locks may extend from the mating surface 111a at or near a distal end of the second portion 122a.
- Two pegs 119a may extend from the mating surface 111a adjacent to the locking member(s) 124a, distal to the pins 118a and proximal to the pegs 119a.
- a second center-split half 110b (e.g., second side, groove side, etc.) of the biopsy cap housing 20 may include a first ( e.g., top) portion 112b defining a second half ( e.g., a substantially hemi-cylindrical half) of the upper chamber, and a second ( e.g., bottom) portion 122b defining a second half ( e.g., a substantially hemi-cylindrical half) of the lower chamber.
- a second locking hook 123b (e.g ., guidewire locking hook) may be attached to or integrally formed with a proximal end of the first portion 112b.
- a second pivot member 114b (e.g., second pivot button, second pivot feature, etc.) may be integrally formed with an approximate midpoint of the first portion 112b, and a second slit 126b ( e.g., opening, etc.) may extend through a sidewall of the first and second portions 112b, 122b and in substantial alignment with ( e.g., one the same side as, directly below, etc.) the second pivot member 114b.
- the second pivot member 114b may include a raised or elevated surface (e.g., enlarged portion, etc.) extending into the first half of the upper chamber, e.g., to engage a corresponding recessed portion 312b ( e.g., groove, indentation, etc.) formed within an outer wall of a biopsy cap 300 ( FIG. 2 ).
- a raised or elevated surface e.g., enlarged portion, etc.
- a corresponding recessed portion 312b e.g., groove, indentation, etc.
- an inner surface of the first portion 112b of the second center-split half 110b may include a surface feature(s) configured to compressingly and/or frictionally engage a corresponding surface feature of the biopsy cap.
- the surface feature(s) may include a lip 117b ( e.g., step feature, etc.) integrally formed with an inner wall of the second center-split half 110b and extending into the first half of the upper chamber at or near a proximal end of the first portion 112b.
- the surface feature(s) may include a pair of wedges 116b (e.g ., indentation, recessed portion, etc.) formed within the inner wall of the second portion 112b distal to the lip 117b and on opposite sides ( e.g., separated by approximately 180 degrees) of the first half of the upper chamber.
- a pair of wedges 116b e.g ., indentation, recessed portion, etc.
- one or more locking members 124b may be attached to or integrally formed with an inner wall of the second center-split half 110b at or near a proximal end of the second portion 122b and on opposite sides ( e.g ., separated by approximately 180 degrees) of the second half of the lower chamber.
- the locking member(s) 124b may be configured to releasably engage the neck 410 of a biopsy port 400 disposed within the lower chamber ( FIG. 4A ).
- an end of the locking member(s) 124b may include a pair of substantially perpendicular surfaces 125b, 127b configured to engage ( e.g., contact, fit within, etc.) a substantially 90-degree surface (e.g., a bottom or lower surface of a lip) of the neck 410 of the biopsy port 400.
- one or more platforms 128b e.g., stops, etc.
- one or more receiving elements may be integrally formed within a mating surface 111b of the first and second portions 112b, 122b of the second center-split half 110b and configured to receive/engage the corresponding one or more projection(s) of the first center-split half 110a in a friction or interference fit, e.g., such that the first and second center-split halves 110a, 110b may interlock in a snap-fit configuration to form an assembled biopsy cap housing 110.
- the receiving element(s) may include one or more pin holes 118b (e.g., posts, rods, etc.) with a substantially spherical or cylindrical inner dimension configured to frictionally receive the corresponding substantially spherical or cylindrical outer dimension of the respective pin(s) 118a.
- the receiving element(s) may include one or more sockets 119b with a substantially square or rectangular inner dimension configured to frictionally receive the corresponding substantially square or rectangular outer dimension of the respective peg(s) 119a.
- the receiving element(s) may include one or more snap-lock receivers 120b with a substantially curved or hooked inner dimension configured to receive the corresponding substantially curved or hooked end of the snap-lock(s) 120a.
- the one or more snap-locks 120a of the present disclosure may include a recessed angled surface 121a configured to frictionally and/or compressingly contact/engage a corresponding angled surface 121b of the respective or more snap-lock receivers 120b.
- the interface between these opposing angled surfaces may provide a "positive locking" interaction with a greater locking force/interaction than between corresponding non-angled surfaces.
- two pin holes 118b may be formed within the mating surface 111b at or near a proximal end of the first portion 112b and two pin holes 118b may be formed within the mating surface 111b adjacent to the locking member(s) 124b.
- Two snap-lock receivers 120b may be formed within the mating surface 111b at or near the proximal end of the first portion 112b and proximal to the pin holes 118b and two snap-lock receiver 120bs may be formed within the mating surface 111b at or near a distal end of the second portion 122b.
- Two sockets 119b may be formed within the mating surface 111b adjacent to the locking member(s) 124b, distal to the pin holes 118b and proximal to the snap-lock receivers 120b.
- a biopsy cap housing 100 of the present disclosure may be assembled by aligning the mating surfaces 111a, 111b of the first and second center-split halves 110a, 110b such that each of the one or more projections (e.g ., pin(s) 118a, peg(s) 119a and snap-lock(s) 120a) is aligned with the corresponding one or more receiving elements (e.g., pin hole(s) 118b, socket(s) 119b and snap-lock receiver(s) 120b) and then compressing or squeezing the first and second center-split halves 110a, 110b together in a snap-fit configuration.
- the one or more projections e.g ., pin(s) 118a, peg(s) 119a and snap-lock(s) 120a
- receiving elements e.g., pin hole(s) 118b, socket(s) 119b and snap-lock receiver(s) 120b
- first and second locking hooks 123a, 123b may be substantially adjacent to each other when the biopsy cap housing 100 is assembled and configured to securely engage a proximal portion of a guidewire.
- the respective surface features of the first portions 112a, 112b of the first and second center-split halves 110a, 110b may substantially aligned to provide contiguous surface features to prevent or limit axial and/or rotational movement of a biopsy cap 300 disposed within the upper chamber and/or to prevent fluid flow ( e.g., leakage) around an outer surface of the biopsy cap 300.
- the lips 117a, 117b of the first and second portions 112a, 112b may align to form a substantially contiguous lip extending into the upper chamber at or near a proximal end of the biopsy cap housing 100 and the wedges 116a, 116b may substantially align to form contiguous wedges on opposites sides of the upper chamber.
- a biopsy cap 300 of the present disclosure may include a surface feature(s) formed on or within the biopsy cap and configured to frictionally and/or compressingly engage a corresponding surface feature formed on or within an inner surface of the first portions of the first and second center-split halves 110a, 110b.
- the biopsy cap 300 may include a first surface feature 314a attached to or integrally formed with a proximal end ( e.g., top surface) of the biopsy cap 300 and second and third surface features 314b, 314c attached to or integrally formed with an outer wall of the biopsy cap 300.
- the surface feature(s) may include first and second recessed portions 312a, 312b integrally formed within an outer wall of the biopsy cap 300 and separated from the second and third surface features 314b, 314c by approximately 90-degrees relative to an outer circumference of the biopsy cap 300.
- a biopsy cap 300 of the present disclosure may be formed from or otherwise include a variety of compressible materials (e.g., silicone, rubbers, etc.) formed as a single unitary structure using, e.g., co-extrusion or co-molding techniques as are known in the art.
- the biopsy cap housing 20 and/or biopsy cap 300 of the present disclosure may frictionally and/or compressingly engage a substantially planar top surface of the first surface feature 314a of the biopsy cap 300.
- the contiguous wedges on opposite sides of the first portion may frictionally and/or compressingly engage a substantially planar top surface and/or angled side surface of the respective corresponding second and third surface features 314b, 314c of the biopsy cap 300 and a base 45.
- the elevated surfaces of the first and second pivot members 114a, 114b may frictionally and/or compressingly engage corresponding recessed portions 312a, 312b formed within an outer wall of a biopsy cap 300.
- the cumulative effect of these frictional and/or compressive forces along various opposing surfaces and sides of the biopsy cap 300 may limit or prevent axial and/or rotational movement of the biopsy cap 300 within the first portion (upper chamber) of the biopsy cap housing 100 and/or prevent fluid flow (e.g., leakage) around an outer surface of the biopsy cap 300, e.g., during device exchange through a lumen 310 of the biopsy cap 300.
- the interlocking projections and receiving elements of the respective first and second center-split halves 110a, 110b may provide structural support, minimize movement and equally distribute radially outward forces exerted on the biopsy cap housing 100 across and/or between the first and second center-split halves 110a, 110b.
- radial outward forces exerted on the biopsy cap housing 100 during exchange of a large (e.g., 16-French) medical instrument through the flexible biopsy cap 300 may be distributed substantially equally along a full length of the biopsy cap housing 100 ( e.g., between/along mating surfaces 111a, 111b) rather than concentrated within the upper chamber.
- radial outward forces applied unequally to one side of the biopsy cap housing 100, e.g., by a guidewire secured to the first and/or second locking hooks 123a, 123b may be redistributed substantially equally along a full length of the biopsy cap housing 100.
- the larger surface area of the interlocking peg(s) 119a/sockets 119b may provide additional structural support, minimize movement and equally distribute forces at or near the lower portion of the biopsy cap housing 100, e.g., adjacent to the locking member(s) 124a, 124b which reversibly engage the neck 410 of the endoscope biopsy port 400.
- first and second pivot members 114a, 114b of the respective first and second center-split halves 110a, 110b may include an increased thickness (e.g., as compared to the remaining wall thickness of the first portions 112a, 112b of the first and second center-split halves 110a, 110b) to provide a strengthened or otherwise fortified section of the biopsy cap housing 100 at a pivot point (e.g.
- a user may inwardly compress the second portions 122a, 122b of the biopsy cap housing 100 such that the first portions 112a, 112b of the first and second center-split halves 110a, 110b move away from each other and the second portions 122a, 122b of the first and second center-split halves 100a, 110b move towards each other to engage the locking members 124a, 124b of the lower chamber with the neck 410 of the endoscope biopsy port 400 ( FIG. 4A ).
- a user may inwardly compress the first portions 112a, 112b of the biopsy cap housing 100 such that the first portions 112a, 112b of the center-split halves 110a, 110b move toward each other and the second portions 122a, 122b of the first and second center-split halves 110a, 110b move away from each other to disengage the locking members 124a, 124b from the neck 410 of the endoscope biopsy port 400.
- the shape, location and/or thickness of the first and second pivot members 114a, 114b may provide increased strength and/or flexibility as compared to a corresponding pivot point of a conventional biopsy cap housing without increasing the overall amount of material at the first and second pivot members 114a, 114b.
- the substantially equal distribution of forces throughout the biopsy cap housing 100 may reduce the cumulative effects of wear-and-tear resulting from incremental and persistent movement between the interlocking projections and receiving elements and/or prevent partial or complete disengagement of the lower housing from the neck 410 of the endoscope biopsy port 400.
- the locking members 124a, 124b may releasably engage the neck 410 of a biopsy port 400 disposed within the lower chamber, e.g ., when the second portions 122a, 122b of the biopsy cap housing 100 are inwardly compressed towards each other.
- FIG. 4B with the locking members 124a, 124b releasably engaged with the neck 410 of the biopsy port 400, and end of the locking members 124a, 124b may be separated from a surface 129a, 129b ( e.g., enlarged or thickened surface) of a respective platform 128a, 128b by a distance.
- the ends of the locking members 124a, 124b may contact the respective surface 129a, 129b of the platforms 128a, 128b to prevent the locking members 124a, 124b from over-extending to a point of fracture.
- the surfaces 129a, 129b may prevent the locking members 124a, 124b from extending past the respective the platforms 128a, 128b to a point at which one or both of the locking members 124a, 124b might break or otherwise fracture.
- the platform 128a, 128b may be configured or positioned to allow the locking members 124a, 124b to bend or flex approximately 15-degrees and not greater than approximately 25-degrees.
- the ability of the platforms of the stabilizers 128a, 128b to prevent over-extension of the locking members 124a, 124b may further prevent or minimize the cumulative effects of wear-and-tear resulting from incremental and persistent over-extension of the locking members 124a, 124b before or following repeated engagement and disengagement with the neck 410 of the endoscope biopsy port 400.
- the first and second center-split halves 110a, 110b may be integrally formed from (co-molded, co-extruded, injection molded etc.) a variety of high-quality polymers (e.g ., acetyl, etc.) which may provide the requisite yield strain and force modulus to withstand the various radial and load forces exerted on the biopsy cap housing 100 while also maintaining sufficient flexibility to be opened or closed using the force applied by a user's fingers.
- high-quality polymers e.g ., acetyl, etc.
- the present disclosure is not limited to embodiments in which the one or more projections are located exclusively on a mating surface of the first center-split half and the corresponding one or more receiving elements are located exclusively on a mating surface of the second center-split half.
- the one or more projections may be located on a mating surface of the second center-split half and the corresponding one or more receiving elements may be located on a mating surface of the first center-split half.
- the mating surface of the first center-split half may include both projections and receiving elements configured to receive and/or be received within corresponding receiving elements and projections on the mating surface of the second center-split half.
Description
- This application claims the benefit of priority under 35 USC § 119 to
United States Provisional Patent Application Serial No. 62/755,024, filed November 2, 2018 United States Provisional Patent Application Serial No. 62/768,808, filed November 16, 2018 United States Provisional Patent Application Serial No. 62/834,192, filed April 15, 2019 United States Provisional Patent Application Serial No. 62/834,201, filed April 15, 2019 - The present disclosure relates generally to the field of medical instruments. More particularly, the present disclosure pertains to medical instruments for use with an endoscope, such as a biopsy cap and a biopsy cap housing with improved stability and stress distribution, for example, to securely attach to an endoscope biopsy port.
- Conventional endoscope biopsy cap housings and biopsy caps can include a variety of deficiencies which may contribute - both individually and cumulatively - to component breakage, unnecessarily complicated or additional procedural steps and/or prolonged procedure times. For example, conventional biopsy cap housings tend to permit axial and rotational movement of the housing and/or cap during device exchange. In addition, exchange of larger diameter medical instruments (e.g., catheters, stent introducers, etc.) through the biopsy cap tends to exert a radially outward force which may cause the two center-split halves of conventional biopsy cap housings to partially or completely separate/disengage from each other. Adhesives applied to the center-split halves may minimize such separation but result in increased assembly time and cost. Locking or unlocking a guidewire to the hook(s) located on one side of a conventional biopsy cap housing tends to exert a radially outward force on one of the center-split halves, which may cause the center-split halves to move in opposite directions and partially or completely separate/disengage from each other. Excessive flexing due to lateral forces applied to one or both center-split halves, e.g., during disengagement of the biopsy cap housing from the biopsy port, may concentrate stress on the locks which secure the biopsy cap housing to the endoscope port, resulting in a fracture of one or more of the locks. Any fracturing of components or separation between the center-split halves resulting from these forces may result in compromised stability between the biopsy cap housing and the endoscope biopsy port. In addition, the cumulative effects of these separation forces may decrease the operational longevity of the biopsy cap housing. Prior art document
US 2006/195117 discloses a wire guide holder having a seal and a body is provided. The seal is adapted to receive a wire guide, and the body is attached to the seal and is adapted to be attached to an elongate medical tube. The elongate medical tube may include an endoscope. The endoscope may have an access port and an insert, and the body may be affixed to the access port. The body may also be affixed to an insert, insert groove, or insert rim. The body may be snap-fit together. - A variety of advantageous medical outcomes may therefore be realized by the biopsy cap and biopsy cap housing embodiments of the present disclosure.
- In one aspect, the present disclosure relates to a biopsy cap housing comprising a first center-split half and a second center-split half. The first center-split half may include a first portion defining a first half of an upper chamber and a second portion defining a first half of a lower chamber. A first pivot member may be integrally formed with the first portion of the first center-split half. A first slit may extend through a sidewall of the first and second portions of the first center-split half and in substantial alignment with the first pivot member. The second center-split half may include a first portion defining a second half of the upper chamber and a second portion defining a second half the lower chamber. A second pivot member may be integrally formed with the first portion of the second center-split half. A second slit may extend through a sidewall of the first and second portions of the second center-split half and in substantial alignment with the second pivot member. Mating surfaces of the first and second center-split halves may be configured to interlock to define the upper and lower chambers.
- In the described and other embodiments within the scope of the present disclosure, an elevated surface of the first pivot member may extend into the upper chamber and an elevated surface of the second pivot member may extend into the upper chamber substantially opposite the first pivot member. The upper chamber may be configured to receive a biopsy cap. The lower chamber may be configured to receive an endoscope biopsy port. The first and second pivot members may include a thickness greater than a wall thickness of the first and second center-split halves. A force applied to the first portions of the first and second center-split halves may move the second portions of the first and second center-split halves away from each other. A force applied to the second portions of the first and second center-split halves may move the first portions of the first and second center-split halves away from each other. The elevated surfaces of the first and second pivot members may be configured to engage a corresponding recessed portion formed within an outer wall of a biopsy cap disposed within the upper chamber. A first locking hook may be attached to a proximal end of the first center-split half and a second locking hook may attached to a proximal end of the second center-split half. The first and second locking hooks may be substantially adjacent to each other when the first and second center-split halves are interlocked. An inner surface of the first portions of the first and second center-split halves may include a surface feature configured to engage a corresponding surface feature formed on or within an outer wall of a biopsy cap disposed within the upper chamber. The surface feature of the housing may include a lip extending into a proximal end of the upper chamber. The surface feature of the biopsy cap may include a wedge extending inward from a top surface of the biopsy cap. The lip may be configured to engage the top surface of the wedge of the biopsy cap. The surface feature of the housing may include a wedge formed within the inner surfaces of the first and second portions of the first and second center-split halves. The surface feature of the biopsy cap may include a wedge extending outward from an outer wall of the biopsy cap top. The wedge of the housing may be configured to engage the wedge of the biopsy cap. The mating surface of the first center-split half may include one or more projections and the mating surface of the second center-split half may include one or more receiving elements. The projections may be configured to be received within corresponding receiving elements. The one or more projections may include one or more pins and the one or more receiving elements may include one or more pin holes. The one or more pins and corresponding one or more pin holes may be located at a proximal end of the first portions of the first and second center-split halves. The one or more pins and corresponding one or more pin holes may be located at a proximal end of the second portions of the first and second center-split halves. The one or more projections may include one or more pegs and the one or more receiving elements may include one or more sockets. The one or more pegs and corresponding one or more sockets may be located at a proximal end of the second portions of the first and second center-split halves. The one or more projections may include one or more snap-locks and the one or more receiving elements may include one or more snap-lock receivers. The one or more snap-locks and corresponding one or more snap-lock receivers may be located at a proximal end of the first portions of the first and second center-split halves. The one or more snap-locks and corresponding one or more snap-lock receivers may be located at a proximal end of the second portions of the first and second center-split halves. The one or more snap-locks may include an angled surface configured to positively engage a corresponding angled surface of the one or more snap-lock receivers. An inner surface of the second portions of the first and second center-split halves may include one or more locking members extending into the lower chamber and configured to releasably engage an outer surface of an endoscope biopsy port disposed within the lower chamber. An inner surface of the second portions of the first and second center-split halves may include one or more platforms extending into the lower chamber on opposite sides of the first and second slits and between the one or more locking members. An end of the one or more locking members and a surface of the one or more platforms may be separated by a distance within the lower chamber when a force is not applied to the first portions of the first and second center-split halves. An end of the one or more locking members and a surface of the one or more platforms may be in contact when a force is applied to the first portions of the first and second center-split halves. The force applied to the first portions of the first and second center-split halves may be an inward compressive force configured to move the second portions of the first and second center-split halves away from each other. The contact between the one or more locking members and the surface of the one or more platforms may prevent at least one of the locking members from breaking due to over-extension.
- In one aspect, the present disclosure relates to a biopsy cap comprising one or more surface features formed on or within the biopsy cap. The one or more surface features may be configured to frictionally and/or compressingly engage a corresponding surface feature formed on or within an inner surface of a first portion of first and second center-split halves of a biopsy cap housing. The biopsy cap may include a first surface feature attached to or integrally formed with a proximal end of the biopsy cap and second and third surface features attached to or integrally formed with an outer wall of the biopsy cap. The one or more surface features may include first and second recessed portions integrally formed within an outer wall of the biopsy cap and separated from the second and third surface features by approximately 90-degrees relative to an outer circumference of the biopsy cap. The biopsy cap may be formed from or otherwise include a variety of compressible materials (e.g., silicone, rubbers, etc.) formed as a single unitary structure using. The surface feature may include a substantially contiguous lip. The surface feature may include substantially contiguous wedges. The surface feature may include recessed portions.
- The present invention as defined in independent claim 1 relates to a biopsy cap assembly comprising a first center-split housing half and a second center-split housing half. The first center-split half may include a first portion defining a first half of an upper chamber and a second portion defining a first half of a lower chamber. A first pivot member may be integrally formed with the first portion of the first center-split half. The second center-split half may include a first portion defining a second half of the upper chamber and a second portion defining a second half the lower chamber. A second pivot member may be integrally formed with the first portion of the second center-split half. Mating surfaces of the first and second center-split housing halves may be configured to interlock to define the upper and lower chambers. A biopsy cap may be disposed within the upper chamber. Preferred embodiments of the invention are defined in the dependent claims.
- In the described and other embodiments within the scope of the present disclosure, an outer wall of the biopsy cap may include recessed portions formed therein. An elevated surface of the first pivot member may extend into the upper chamber and an elevated surface of the second pivot member may extend into the upper chamber substantially opposite the first pivot member. The elevated surfaces may frictionally engage the recessed portions of the biopsy cap. The first and second pivot members may include a thickness greater than a wall thickness of the first and second center-split housing halves. The housing may include a lip extending into a proximal end of the upper chamber and the biopsy cap may include a wedge extending outward from a top surface of the cap. The lip may be configured to engage the top surface of the wedge. The housing may include a wedge formed within the inner surfaces of the first and second portions of the first and second center-split housing halves. The biopsy cap may include a wedge extending outward from an outer wall of the biopsy cap top. The wedge of the housing may be configured to engage the wedge of the biopsy cap.
- Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying figures, which are schematic and not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. In the figures:
-
FIGS. 1A-1C provide perspective views of center-split halves of a biopsy cap housing, according to one embodiment of the present disclosure. -
FIG. 2 provides a perspective view of a biopsy cap, according to one embodiment of the present disclosure. -
FIGS. 3A-3B provide perspective views of biopsy cap disposed within a biopsy cap housing, according to one embodiment of the present disclosure. -
FIGS. 4A-4C provide perspective views of V-locks of a biopsy cap housing, according to one embodiment of the present disclosure. - The present disclosure is not limited to the particular embodiments described herein. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.
- Although embodiments of the present disclosure are described with specific reference to biopsy caps and biopsy cap housings configured to allow the delivery and/or exchange of a variety of medical instruments through the biopsy cap and port of an endoscope, laparoscope, or other visualization systems such as the Spy Glass™ Direct Visualization System (Boston Scientific Corp., Marlborough, MA), it should be appreciated that such designs may be adapted to fit and/or be used with a variety of medical instruments and medical applications which include sealable access.
- As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," or "includes" and/or "including" when used herein, specify the presence of stated features, regions, steps elements and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and/or groups thereof.
- As used herein, the term "distal" refers to the end farthest away from the medical professional when introducing a device into a patient, while the term "proximal" refers to the end closest to the medical professional when introducing a device into a patient.
- In various embodiments, features and advantages of providing sealable access to a working channel, e.g., of an endoscope, may be realized in combination with a biopsy cap and biopsy cap housing. Such sealable access to a working channel, which may be reinforced, may be implemented with features throughout the disclosures of
United States Patent Application Serial No. 16/100,960, filed August 10, 2018 - Referring to
FIGS. 1A-1B , in an embodiment of a biopsy cap housing of the present disclosure may include first and second center-split halves first portion FIG. 2 ) and asecond portion FIG. 4A ). - Referring to
FIG. 1A , in an embodiment, a first center-split half 110a (e.g., first side, lock side, etc.) of thebiopsy cap housing 100 may include a first (e.g., top, upper)portion 112a defining a first half (e.g., a substantially hemi-cylindrical half) of the upper chamber, and a second (e.g., bottom, lower)portion 122a defining a first half (e.g., a substantially hemi-cylindrical half) of the lower chamber. Afirst locking hook 123a (e.g., guidewire locking hook) and a guide are 130 may be attached to or integrally formed with a proximal end of thefirst portion 112a. Afirst pivot member 114a (e.g., first pivot button, first pivot feature, etc.) may be integrally formed with an approximate midpoint of thefirst portion 112a, and afirst slit 126a (e.g., opening, slot, etc.) may extend through a sidewall of the first andsecond portions first pivot member 114a. Thefirst pivot member 114a may include a substantially radially raised or elevated surface (e.g., enlarged portion, projection, etc.) extending into the first half of the upper chamber, e.g., to engage a corresponding recessedportion 312a formed within an outer wall of a biopsy cap 300 (FIG. 2 ). - In an embodiment, an inner surface of the
first portion 112a of the first center-split half 110a may include a surface feature(s) configured to compressingly and/or frictionally engage a corresponding surface feature of a biopsy cap. In some embodiments, the surface feature(s) may include alip 117a (e.g., step feature, etc.) integrally formed with an inner wall of the first center-split half 110a and extending into the first half of the upper chamber at or near a proximal end of thefirst portion 112a. In various embodiments, the surface feature(s) may include a pair ofwedges 116a (e.g., indentations, recessed portions, etc.) formed within the inner wall of thefirst portion 112a distal to thelip 117a and on opposite sides (e.g., separated by approximately 180 degrees) of the first half of thefirst portion 112a. - In an embodiment, one or
more locking members 124a (e.g., V-locks, etc.) may be attached to or integrally formed with an inner wall of the first center-split half 110a at or near a proximal end of thesecond portion 122a and on opposite sides (e.g., separated by approximately 180 degrees) of the first half of thesecond potion 122a. The locking member(s) 124a may be configured to releasably engage a biopsy port 400 (e.g., at neck 410) disposed within thesecond portion 122a (FIG. 4A ). For example, an end of the locking member(s) 124a may include a pair of substantiallyperpendicular surfaces neck 410 of thebiopsy port 400. In addition, one or more platforms (e.g., stops, etc.) may be attached to or integrally formed with an inner wall of the first center-split half 110a on opposite sides of thefirst slit 126a and between the locking member(s) 124a. - In an embodiment, one or more projections may be attached to or integrally formed with a
mating surface 111a of the first andsecond portions split half 110a. In various embodiments, the projection(s) may include one ormore pins 118a (e.g., posts, rods, etc.) with a substantially spherical or cylindrical outer dimension. In various additional embodiments, the projections(s) may include one ormore pegs 119a (e.g., blocks, etc.) with a substantially square or rectangular outer dimension. In various additional embodiments, the projections(s) may include one or more snap-locks 120a (e.g., arms, etc.) with a substantially curved or hooked end. - By way of non-limiting example, in an embodiment, two
pins 118a may extend from themating surface 111a at or near a proximal end of thefirst portion 112a and twopins 118a may extend from themating surface 111a adjacent to the locking member(s) 124a. Two snap-locks 120a may extend from themating surface 111a at or near the proximal end of thefirst portion 112a and proximal to thepins 118a and two snap-locks may extend from themating surface 111a at or near a distal end of thesecond portion 122a. Twopegs 119a may extend from themating surface 111a adjacent to the locking member(s) 124a, distal to thepins 118a and proximal to thepegs 119a. - Referring to
FIG. 1B , in an embodiment, a second center-splithalf 110b (e.g., second side, groove side, etc.) of the biopsy cap housing 20 may include a first (e.g., top)portion 112b defining a second half (e.g., a substantially hemi-cylindrical half) of the upper chamber, and a second (e.g., bottom)portion 122b defining a second half (e.g., a substantially hemi-cylindrical half) of the lower chamber. Asecond locking hook 123b (e.g., guidewire locking hook) may be attached to or integrally formed with a proximal end of thefirst portion 112b. Asecond pivot member 114b (e.g., second pivot button, second pivot feature, etc.) may be integrally formed with an approximate midpoint of thefirst portion 112b, and asecond slit 126b (e.g., opening, etc.) may extend through a sidewall of the first andsecond portions second pivot member 114b. Thesecond pivot member 114b may include a raised or elevated surface (e.g., enlarged portion, etc.) extending into the first half of the upper chamber, e.g., to engage a corresponding recessedportion 312b (e.g., groove, indentation, etc.) formed within an outer wall of a biopsy cap 300 (FIG. 2 ). - In one embodiment, an inner surface of the
first portion 112b of the second center-splithalf 110b may include a surface feature(s) configured to compressingly and/or frictionally engage a corresponding surface feature of the biopsy cap. In one embodiment, the surface feature(s) may include alip 117b (e.g., step feature, etc.) integrally formed with an inner wall of the second center-splithalf 110b and extending into the first half of the upper chamber at or near a proximal end of thefirst portion 112b. In one embodiment, the surface feature(s) may include a pair ofwedges 116b (e.g., indentation, recessed portion, etc.) formed within the inner wall of thesecond portion 112b distal to thelip 117b and on opposite sides (e.g., separated by approximately 180 degrees) of the first half of the upper chamber. - In one embodiment, one or
more locking members 124b (e.g., V-locks, etc.) may be attached to or integrally formed with an inner wall of the second center-splithalf 110b at or near a proximal end of thesecond portion 122b and on opposite sides (e.g., separated by approximately 180 degrees) of the second half of the lower chamber. The locking member(s) 124b may be configured to releasably engage theneck 410 of abiopsy port 400 disposed within the lower chamber (FIG. 4A ). For example, an end of the locking member(s) 124b may include a pair of substantiallyperpendicular surfaces neck 410 of thebiopsy port 400. In addition, one ormore platforms 128b (e.g., stops, etc.) may be attached to or integrally formed with an inner wall of the second center-splithalf 110b on opposite sides of thesecond slit 126b and between the locking member(s) 124b. - In one embodiment, one or more receiving elements (e.g., receiving features, etc.) may be integrally formed within a
mating surface 111b of the first andsecond portions half 110b and configured to receive/engage the corresponding one or more projection(s) of the first center-split half 110a in a friction or interference fit, e.g., such that the first and second center-split halves more pin holes 118b (e.g., posts, rods, etc.) with a substantially spherical or cylindrical inner dimension configured to frictionally receive the corresponding substantially spherical or cylindrical outer dimension of the respective pin(s) 118a. In various additional embodiments, the receiving element(s) may include one ormore sockets 119b with a substantially square or rectangular inner dimension configured to frictionally receive the corresponding substantially square or rectangular outer dimension of the respective peg(s) 119a. In various additional embodiments, the receiving element(s) may include one or more snap-lock receivers 120b with a substantially curved or hooked inner dimension configured to receive the corresponding substantially curved or hooked end of the snap-lock(s) 120a. Referring toFIG. 1C , in one embodiment, the one or more snap-locks 120a of the present disclosure may include a recessedangled surface 121a configured to frictionally and/or compressingly contact/engage a corresponding angled surface 121b of the respective or more snap-lock receivers 120b. In various embodiments, the interface between these opposing angled surfaces may provide a "positive locking" interaction with a greater locking force/interaction than between corresponding non-angled surfaces. - By way of non-limiting example, in one embodiment, two
pin holes 118b may be formed within themating surface 111b at or near a proximal end of thefirst portion 112b and twopin holes 118b may be formed within themating surface 111b adjacent to the locking member(s) 124b. Two snap-lock receivers 120b may be formed within themating surface 111b at or near the proximal end of thefirst portion 112b and proximal to the pin holes 118b and two snap-lock receiver 120bs may be formed within themating surface 111b at or near a distal end of thesecond portion 122b. Twosockets 119b may be formed within themating surface 111b adjacent to the locking member(s) 124b, distal to the pin holes 118b and proximal to the snap-lock receivers 120b. - In one embodiment, a
biopsy cap housing 100 of the present disclosure may be assembled by aligning themating surfaces split halves split halves biopsy cap housing 100 is assembled and configured to securely engage a proximal portion of a guidewire. In addition, the respective surface features of thefirst portions split halves biopsy cap 300 disposed within the upper chamber and/or to prevent fluid flow (e.g., leakage) around an outer surface of thebiopsy cap 300. For example, thelips second portions biopsy cap housing 100 and thewedges - Referring to
FIG. 2 , in one embodiment, abiopsy cap 300 of the present disclosure may include a surface feature(s) formed on or within the biopsy cap and configured to frictionally and/or compressingly engage a corresponding surface feature formed on or within an inner surface of the first portions of the first and second center-split halves biopsy cap 300 may include afirst surface feature 314a attached to or integrally formed with a proximal end (e.g., top surface) of thebiopsy cap 300 and second and third surface features 314b, 314c attached to or integrally formed with an outer wall of thebiopsy cap 300. In addition, or alternatively, the surface feature(s) may include first and second recessedportions biopsy cap 300 and separated from the second and third surface features 314b, 314c by approximately 90-degrees relative to an outer circumference of thebiopsy cap 300. In various embodiments, abiopsy cap 300 of the present disclosure may be formed from or otherwise include a variety of compressible materials (e.g., silicone, rubbers, etc.) formed as a single unitary structure using, e.g., co-extrusion or co-molding techniques as are known in the art. - In various embodiments, a variety of advantages may be realized by the biopsy cap housing 20 and/or
biopsy cap 300 of the present disclosure. For example, referring toFIG. 3A , in an embodiment the substantially contiguous lip (e.g., formed byrespective lips halves biopsy cap housing 100 may frictionally and/or compressingly engage a substantially planar top surface of thefirst surface feature 314a of thebiopsy cap 300. In addition, or alternatively, the contiguous wedges on opposite sides of the first portion (e.g., formed byrespective wedges biopsy cap 300 and abase 45. Referring toFIG. 3B , in addition or alternatively, the elevated surfaces of the first andsecond pivot members portions biopsy cap 300. - In various embodiments, the cumulative effect of these frictional and/or compressive forces along various opposing surfaces and sides of the
biopsy cap 300 may limit or prevent axial and/or rotational movement of thebiopsy cap 300 within the first portion (upper chamber) of thebiopsy cap housing 100 and/or prevent fluid flow (e.g., leakage) around an outer surface of thebiopsy cap 300, e.g., during device exchange through alumen 310 of thebiopsy cap 300. - In addition, or as an alternative, to the above-described advantages, a variety of additional advantages may be realized by the interlocking projections and receiving elements of the respective first and second center-
split halves biopsy cap housing 100 across and/or between the first and second center-split halves biopsy cap housing 100 during exchange of a large (e.g., 16-French) medical instrument through theflexible biopsy cap 300 may be distributed substantially equally along a full length of the biopsy cap housing 100 (e.g., between/alongmating surfaces biopsy cap housing 100, e.g., by a guidewire secured to the first and/or second locking hooks 123a, 123b may be redistributed substantially equally along a full length of thebiopsy cap housing 100. In addition, or alternatively, the larger surface area of the interlocking peg(s) 119a/sockets 119b (e.g., as compared to the pin(s)118a/pinhole(s)118b) at or near the locking member(s) 124a, 124b may provide additional structural support, minimize movement and equally distribute forces at or near the lower portion of thebiopsy cap housing 100, e.g., adjacent to the locking member(s) 124a, 124b which reversibly engage theneck 410 of theendoscope biopsy port 400. - In addition, or as an alternative, to any of the above-described advantages, a variety of additional advantages may be realized by the first and
second pivot members split halves portions biopsy cap 300, the first andsecond pivot members first portions split halves biopsy cap housing 100 at a pivot point (e.g., high-stress portion) between the upper and lower chambers. For example, a user may inwardly compress thesecond portions biopsy cap housing 100 such that thefirst portions split halves second portions split halves 100a, 110b move towards each other to engage thelocking members neck 410 of the endoscope biopsy port 400 (FIG. 4A ). Similarly, a user may inwardly compress thefirst portions biopsy cap housing 100 such that thefirst portions split halves second portions split halves locking members neck 410 of theendoscope biopsy port 400. In various embodiments, the shape, location and/or thickness of the first andsecond pivot members second pivot members - As will be understood by those of skill in the art, the substantially equal distribution of forces throughout the
biopsy cap housing 100, including radially outward forces due to device exchange or guidewire locking and high-stress forces at the pivot points due to attachment/removal from the biopsy port, may reduce the cumulative effects of wear-and-tear resulting from incremental and persistent movement between the interlocking projections and receiving elements and/or prevent partial or complete disengagement of the lower housing from theneck 410 of theendoscope biopsy port 400. - Referring to
FIG. 4A , in one embodiment, the lockingmembers neck 410 of abiopsy port 400 disposed within the lower chamber, e.g., when thesecond portions biopsy cap housing 100 are inwardly compressed towards each other. Referring toFIG. 4B , with the lockingmembers neck 410 of thebiopsy port 400, and end of thelocking members surface respective platform FIG. 4C , with the locking members disengaged from theneck 410 of thebiopsy port 400, e.g., when thefirst portions biopsy cap housing 100 are inwardly compressed towards each other, the ends of thelocking members respective surface platforms locking members surfaces locking members platforms locking members platform locking members - In addition, or as an alternative, to any of the above-described advantages, the ability of the platforms of the
stabilizers locking members locking members neck 410 of theendoscope biopsy port 400. - In various embodiments, the first and second center-
split halves biopsy cap housing 100 while also maintaining sufficient flexibility to be opened or closed using the force applied by a user's fingers. - The present disclosure is not limited to embodiments in which the one or more projections are located exclusively on a mating surface of the first center-split half and the corresponding one or more receiving elements are located exclusively on a mating surface of the second center-split half. In various embodiments, the one or more projections may be located on a mating surface of the second center-split half and the corresponding one or more receiving elements may be located on a mating surface of the first center-split half. In various additional embodiments, the mating surface of the first center-split half may include both projections and receiving elements configured to receive and/or be received within corresponding receiving elements and projections on the mating surface of the second center-split half.
- The invention is defined in the appended claims.
Claims (15)
- A biopsy cap assembly, comprising:
a biopsy cap housing, comprising:
a first center-split half (110a) comprising:a first portion (112a) defining a first half of an upper chamber,a second portion (122a) defining a first half of a lower chamber,a first pivot member (114a) integrally formed with the first portion of the first center-split half; anda second center-split half (110b) comprising:a first portion (112b) defining a second half of the upper chamber,a second portion (122b) defining a second half of the lower chamber,a second pivot member (114b) integrally formed with the first portion of the second center-split half;wherein mating surfaces (111a, 111b) of the first and second center-split halves are configured to interlock to define the upper and lower chambers; anda biopsy cap (300) disposed within the upper chamber. - The biopsy cap assembly of claim 1, wherein a surface feature (314a, 314b, 314c) formed on or within the biopsy cap is configured to frictionally and/or compressingly engage with a surface feature (116a, 116b, 117a, 117b) formed on or within an inner surface of the first portion (112a, 112b) of the first and second center-split halves (1 10a. b).
- The biopsy cap assembly of claim 1 or 2, wherein a first slit (126a) extends through a sidewall of the first and second portions of the first center-split half and is in substantial alignment with the first pivot member, and a second slit (126b) extends through a sidewall of the first and second portions of the second center-split half and is in substantial alignment with the second pivot member.
- The biopsy cap assembly of any one of claims 1-3, wherein an elevated surface of the first pivot member (114a) extends into the upper chamber and an elevated surface (114b) of the second pivot member (114b) extends into the upper chamber substantially opposite the first pivot member.
- The biopsy cap assembly of claim 4, wherein the first and second pivot members include a thickness greater than a wall thickness of the first and second center-split halves.
- The biopsy cap assembly of any one of claims 4-5, wherein the elevated surfaces of the first and second pivot members are configured to engage a corresponding recessed portion (312a, 312b) formed within an outer wall of the biopsy cap.
- The biopsy cap assembly of any one of claims 1-6, wherein the surface feature of the housing includes a pair of lips (117a, 117b) integrally formed with an inner wall of the first and second center-split halves and extending into the first half of the upper chamber at or near a proximal end of the first portion.
- The biopsy cap assembly of claim 7, wherein the lips (117a, 117b) align to form a substantially contiguous lip extending into the upper chamber at or near a proximal end of the housing.
- The biopsy cap assembly of claim 8, wherein the biopsy cap includes a first surface feature (314a) attached to or integrally formed with a proximal end of the biopsy cap and the substantially contiguous lip frictionally and/or compressingly engages with a substantially planar top surface of the first surface feature (314a).
- The biopsy cap assembly of any one of claims 7-8, wherein the surface feature of the housing includes a pair of wedges (116a, 116b) formed within the inner wall of the first portion distal to the pair of lips and on opposite sides of the first half of the first portion, wherein optionally the wedges (116a, 116b) substantially align to form contiguous wedges on opposite sides of the upper chamber,
wherein further optionally the biopsy cap includes second and third surface features (314b, 314c) attached to or integrally formed with an outer wall of the biopsy cap, and the contiguous wedges frictionally and/or compressingly engage a substantially planar top surface and/or angled side surface of the respective corresponding second and third surface feature (314b, 314c). - The biopsy cap assembly of any of claims 1-10, wherein an inner surface of the second portions (122a, 122b) of the first and second center-split halves include one or more locking members (124a, 124b) extending into the lower chamber, and wherein the inner surface of the second portions of the first and second center-split halves include one or more platforms (128a, 128b) extending into the lower chamber on opposite sides of the first and second slits and between the one or more locking members.
- The biopsy cap assembly of claim 11, wherein the one or more locking members are two locking members (124a, 124b), and wherein the two locking members releasably engage a neck (410) of a biopsy port (400) disposed within the lower chamber, when second portions (122a, 122b) of the housing are inwardly compressed towards each other.
- The biopsy cap assembly of claim 12, wherein, when the locking members releasably engage the neck of the biopsy port, an end of the locking members is separated from a surface (129a, 129b) of the respective platform (128a, 128b).
- The biopsy cap assembly of any one of claims 12-13, wherein, when the locking members are disengaged from the neck of the biopsy port, an end of the locking members contacts a surface (129a, 129b) of the respective platform (128a, 128b).
- The biopsy cap assembly of any one of claims 12-14, wherein an end of the locking members includes a pair of substantially perpendicular surfaces (125a, 125b) configured to engage a substantially 90-degree surface of the neck of the biopsy port.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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EP24152468.5A EP4344607A2 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
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US201862768808P | 2018-11-16 | 2018-11-16 | |
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US201962834201P | 2019-04-15 | 2019-04-15 | |
PCT/IB2019/059404 WO2020089857A1 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
EP19805743.2A EP3817636B1 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
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EP19805743.2A Division EP3817636B1 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
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EP24152468.5A Division-Into EP4344607A2 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
EP24152468.5A Division EP4344607A2 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
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EP4111939B1 true EP4111939B1 (en) | 2024-02-28 |
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EP22186025.7A Active EP4111939B1 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
EP19805745.7A Active EP3826524B1 (en) | 2018-11-02 | 2019-11-01 | Internal seal for biopsy cap |
EP23189632.5A Pending EP4260791A3 (en) | 2018-11-02 | 2019-11-01 | Devices for providing sealable access to a working channel |
EP19813130.2A Active EP3813631B1 (en) | 2018-11-02 | 2019-11-01 | Devices and systems for a biopsy cap and housing |
EP23157899.8A Pending EP4215102A1 (en) | 2018-11-02 | 2019-11-01 | Devices, systems, and methods for providing sealable access to a working channel |
EP23175494.6A Pending EP4233682A3 (en) | 2018-11-02 | 2019-11-01 | Attachments for endoscopes |
EP19805746.5A Active EP3817638B1 (en) | 2018-11-02 | 2019-11-01 | Attachments for endoscopes |
EP23161081.7A Pending EP4218531A1 (en) | 2018-11-02 | 2019-11-01 | Devices, systems, and methods for a biopsy cap and housing |
EP19805747.3A Active EP3817639B1 (en) | 2018-11-02 | 2019-11-01 | Devices and systems for providing sealable access to a working channel |
EP24152468.5A Pending EP4344607A2 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
EP19805744.0A Active EP3817637B1 (en) | 2018-11-02 | 2019-11-01 | Devices for providing sealable access to a working channel |
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EP19805743.2A Active EP3817636B1 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
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EP19805745.7A Active EP3826524B1 (en) | 2018-11-02 | 2019-11-01 | Internal seal for biopsy cap |
EP23189632.5A Pending EP4260791A3 (en) | 2018-11-02 | 2019-11-01 | Devices for providing sealable access to a working channel |
EP19813130.2A Active EP3813631B1 (en) | 2018-11-02 | 2019-11-01 | Devices and systems for a biopsy cap and housing |
EP23157899.8A Pending EP4215102A1 (en) | 2018-11-02 | 2019-11-01 | Devices, systems, and methods for providing sealable access to a working channel |
EP23175494.6A Pending EP4233682A3 (en) | 2018-11-02 | 2019-11-01 | Attachments for endoscopes |
EP19805746.5A Active EP3817638B1 (en) | 2018-11-02 | 2019-11-01 | Attachments for endoscopes |
EP23161081.7A Pending EP4218531A1 (en) | 2018-11-02 | 2019-11-01 | Devices, systems, and methods for a biopsy cap and housing |
EP19805747.3A Active EP3817639B1 (en) | 2018-11-02 | 2019-11-01 | Devices and systems for providing sealable access to a working channel |
EP24152468.5A Pending EP4344607A2 (en) | 2018-11-02 | 2019-11-01 | Biopsy cap and biopsy cap housing |
EP19805744.0A Active EP3817637B1 (en) | 2018-11-02 | 2019-11-01 | Devices for providing sealable access to a working channel |
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